MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number	GF-UCT180
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.After olympus staff discussed with the user facility about increase the disinfection time and manual cleaning, no microbes were detected in the subject device.Olympus medical systems corp.(omsc) reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, the sample collected from the instrument channel and the auxiliary channel of the subject device tested positive for pseudomonas aeruginosa, klebsiella and maltophilia.The device had been reprocessed with automatic endowasher chyong cyw 201 model using cidex for disinfection.Other detailed information such as the number of microbes was not provided.There was no report of infection associated with this report.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Common Device Name: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9367992
• Report Number: 8010047-2019-04065
• Device Sequence Number: 2866842
• Product Code: ODG
• UDI-Device Identifier: 04953170355462
• UDI-Public: 04953170355462
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1